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Ortho Shop
Orthoshop, LLC · Model 9202 · UDI-DI 00810152071663
0
510(k) clearances
4
Adverse events
10
Recalls
105
Facilities
Description
Crimpable Split Stops
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
| 2015-03-09 | Specialty Appliance Works, Inc. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.